Genetic Predisposition to DiseaseAHC-BHSNCT05661318
AHC Ballana Heart Study
An observational study of Genetic Predisposition to Disease, run by Magdi Yacoub Heart Foundation at 1 site in Egypt.
Trial summary
This Study is designed to assess CVD incidence, prevalence, progression and related risk factors, including genetic background. It will provide an important base for all cardiovascular research activities in our centre and help in designing future studies and guide policy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Genetic Predisposition to Disease
- What is being tested?
- Risk assessment
- How many people
- 5,000 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 31 Jan 2055
- How long will I take part?
- 30 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: • Residents of Ballana from the 1,200 randomly selected households
Who may be able to join
- Residents of Ballana from the 1,200 randomly selected households
- Participants must have a valid National ID card
- Written informed consent
Who cannot join
- Residents who are younger than 18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Aswan Heart Centre - Magdi Yacoub Heart Foundation
Aswān
Ahmed M ElGuindy, MD, MRCP, +201001615151, ahmed_elguindy@hotmail.com
Shehab M Anwer, MD, +41788816333, shehabanwer@gmail.com
About this study
Official title: Aswan Heart Centre - Ballana Heart Study
This Study is designed to assess CVD incidence, prevalence, progression and related risk factors, including genetic background. It will provide an important base for all cardiovascular research activities in our centre and help in designing future studies and guide policy.
Read the detailed description
Background Population-based longitudinal studies are a cornerstone in understanding current disease landscapes affecting communities and collecting reliable data to guide prevention and treatment strategies. In Egypt there is pressing need of collecting reliable data on cardiovascular disease (CVD) in defined populations.
Objectives Defining the cardiovascular phenotype, genotype as well as OMICS and risk factors for CVD in a defined population in Egypt with follow up for up to 30 years
Methods As a first step, a random representative sample of 1,200 households from the Ballana population will be created. Following inclusion, patients will be screened for their cardiovascular profile and followed up for changes in their profile and cardiovascular events continuously every year in high risk patients and every 3 years for the rest of the participants for a period of 30 years.
- Conditions
- Genetic Predisposition to Disease
- Being tested
- Risk assessment
- Keywords
- genetics, Cardiovascular risks
- Medical subject headings
- Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk assessmentOther
Collect clinical, laboratoary and genetics data from the participants after informed consent
| Study group | Role | What they receive |
|---|---|---|
| BHS | Residents of Ballana from the 1,200 randomly selected households Receives: Other: Risk assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular risk assessment
Measured: 30 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start1 Jan 2018
- Primary completion31 Dec 2050 (estimated)
- Study completion31 Jan 2055 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Genetic Predisposition to DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 30 Years
Sponsor and investigators
- Lead sponsor
- Magdi Yacoub Heart Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magdi H Yacoub, FRS OM, Principal investigator, Imperial College London, and Magdi Yacoub Heart Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661318
- Sponsor's protocol ID
- AHC-BHS
- Acronym
- AHC-BHS
- Status last verified
- May 2024
- First submitted
- 14 Dec 2022
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Keates AK, Mocumbi AO, Ntsekhe M, Sliwa K, Stewart S. Cardiovascular disease in Africa: epidemiological profile and challenges. Nat Rev Cardiol. 2017 May;14(5):273-293. doi: 10.1038/nrcardio.2017.19. Epub 2017 Feb 23.
PubMed 28230175
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aswan Heart Centre - Ballana Heart Study
- ClinicalTrials.gov ID
- NCT05661318
- Acronym / sponsor ID
- AHC-BHS / AHC-BHS
- Conditions
- Genetic Predisposition to Disease
- Keywords
- genetics, Cardiovascular risks
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Magdi Yacoub Heart FoundationUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2050 (estimated)
- Study completion
- 31 Jan 2055 (estimated)
- First posted
- 22 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Study is designed to assess CVD incidence, prevalence, progression and related risk factors, including genetic background. It will provide an important base for all cardiovascular research activities in our centre and help in designing future studies and guide policy.
Detailed description
Background Population-based longitudinal studies are a cornerstone in understanding current disease landscapes affecting communities and collecting reliable data to guide prevention and treatment strategies. In Egypt there is pressing need of collecting reliable data on cardiovascular disease (CVD) in defined populations.
Objectives Defining the cardiovascular phenotype, genotype as well as OMICS and risk factors for CVD in a defined population in Egypt with follow up for up to 30 years
Methods As a first step, a random representative sample of 1,200 households from the Ballana population will be created. Following inclusion, patients will be screened for their cardiovascular profile and followed up for changes in their profile and cardiovascular events continuously every year in high risk patients and every 3 years for the rest of the participants for a period of 30 years.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 30 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BHS | – | Other: Risk assessmentResidents of Ballana from the 1,200 randomly selected households |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- • Residents of Ballana from the 1,200 randomly selected households
Key inclusion criteria (3 listed)
- Residents of Ballana from the 1,200 randomly selected households
- Participants must have a valid National ID card
- Written informed consent
Key exclusion criteria (1 listed)
- Residents who are younger than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk assessmentCollect clinical, laboratoary and genetics data from the participants after informed consent | Other | BHS |
Primary outcome
Cardiovascular risk assessment
Time frame: 30 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Background: PubMed 28230175Keates AK, Mocumbi AO, Ntsekhe M, Sliwa K, Stewart S. Cardiovascular disease in Africa: epidemiological profile and challenges. Nat Rev Cardiol. 2017 May;14(5):273-293. doi: 10.1038/nrcardio.2017.19. Epub 2017 Feb 23.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Magdi H Yacoub, FRS OM principal investigator
Imperial College London, and Magdi Yacoub Heart Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genetic Predisposition to Disease, run by Magdi Yacoub Heart Foundation at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yasmine Aguib, PhD (+201092036368, yasmine.aguib@aswanheartcentre.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular risk assessment (time frame: 30 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05661318, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.